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SRHRL Past Project: Exploring Legal Challenges to Fulfilling the Potential of mHealth in a Safe and Responsible Environment

AAAS received a grant from the Robert Wood Johnson Foundation to pursue a project on mobile health (mHealth) and the law.


Mobile Health App Developers Seek Guidance on Federal Regulation
23 November 2015

About the Project

The past decade has seen rapid, even exponential, growth in the adoption of mobile devices, with over six billion currently in use. Not surprisingly, as this technology becomes part of our everyday lives, it offers the opportunity for patients and other consumers to manage their own health and wellness, for health care professionals to monitor patients wherever they are, and for physiological functions to be altered via wireless communications. These applications, or apps, are commonly referred to as mHealth, the use of mobile communications in health care.

However, new technologies or new uses of existing technologies pose challenges as well as promises, risks as well as benefits. As health care moves from paper to wirelessly transmitted electronic records, from face-to-face encounters between patients and their doctors to digital encounters, and between devices at the bedside to devices implanted in the body, questions arise regarding safety, reliability, privacy, security, and responsibility. Each of these questions raises issues at the intersection of science, technology, health, and law. These issues need to be addressed more fully in order for the potential of mHealth to be achieved in a safe and responsible manner.

We convened three two-day workshops at AAAS headquarters, with each focusing on a single topic - regulation and safety, privacy and security, and liability and responsibility. For each workshop, the 25-30 invited participants included individuals from the sectors necessary for exploring a topic in depth: health professionals, lawyers, patient safety experts, payers, industry representatives, technologists, regulators, policy makers from the legislative and executive branches, and patient advocates. Each workshop was expected to produce recommendations aimed at an array of stakeholders, both in and out of government.

Project Advisory Committee

  • Richard Katz, George Washington University
  • James Kelly, Food and Drug Law Institute (emeritus) 
  • Santosh Kumar, University of Memphis
  • Carol Ley, 3M       
  • Joseph Rosenbaum, Reed Smith LLP
  • Payal Shah, C-Change 
  • Bradley Thompson, Epstein, Becker, and Green                                                       

Workshop 1: Regulation and Safety

The first mHealth workshop was held June 16-17, 2014 at AAAS. The goal of the workshop was to assist AAAS in setting forth the principles and requirements for a regulatory framework that promotes development of mHealth devices and apps, while protecting the public from undue risk. View the workshop agenda and list of participants, as well as the four commissioned papers on mHealth regulation.

Workshop 1 Report

Workshop 2: Privacy

The second mHealth workshop was held October 6-7, 2014 at AAAS. The goal of the workshop was to set forth the principles, policies, and security-related technologies necessary for the development of mHealth devices and apps to improve patient health, while at the same time protecting user privacy. View the workshop agenda and list of participants, as well as the three commissioned papers on mHealth privacy and security.  

Workshop 3: Liability

The third mHealth workshop was held May 14-15, 2015 at AAAS. The goal of the workshop was to assist AAAS in addressing principles of fairness and responsibility that can constitute a framework for liability in a mobile health environment. View the workshop agenda and list of participants, as well as the four commissioned papers on mHealth liability and responsibility. 

The mHealth and Law workshops were supported by a grant from the Robert Wood Johnson Foundation.